Job Details

• Manage distribution activities for clinical studies, troubleshoot depot to site shipments, set rush shipments. Interface with internal and external contacts as required.
• Manage labeling (in multiple languages), packaging, inventory, distribution, and reconciliation of IMP/CTM for multi-national clinical studiesIn conjunction with Clinical
• Operations and Quality Assurance, develop requirements for clinical study drug and other drug supply as required (GLP, non-GLP non-clinical), including label copy, packaged product specifications, product shipping and storage specifications.
• Work with Clinical Operations and outside vendors to design and implement the IXRS system used to automate the distribution of IMP/CTM to drug depots and clinical sites
• Maintain and ensure compliance with all applicable CTM material import / export regulations.
• Develop new functional SOPs, as necessary, and provide training on CTM to staff.
• Develop and maintain applicable metrics to monitor performance relative to clinical trial inventory and planningProvide general CMC support to projects and products, as needed

Education and/or experience:

• Bachelors Degree in applicable discipline and a minimum of 3 to six years professional experience, or equivalent experience, in pharmaceutical/biotech industry and two years minimum experience with IMP/CTM supply management.
• Experience in managing complex distribution IMP/CTM supply chains for double-blinded, placebo-controlled clinical trials in multiple geographiesUnderstanding of CFR and ICH guidelines,
• Regulations and guidelines governing conduct of clinical studies a must
• Demonstrated working knowledge of international regulations governing transport and distribution of CTM materials Flexibility to travel on company business as required

• Excellent written and verbal communication skillsFamiliar with IMP labeling requirmentw
• Accuracy and attention to detailExperience with GMP manufacture of drug products for clinical use is a plus
• Broad exposure to multiple dosage forms is a plus.
• Strong interpersonal skills and ability to function in a dynamic cross-functional team environment.
• Strong computer skills, with proficiency in spreadsheet, presentation and word processing software Adaptability, flexibility, independence, and resourcefulness to multi-task as needed to thrive in a dynamic small company environment